BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel is an FDA 510(k)-cleared medical device (K232954) manufactured by Biofire Diagnostics, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2024. Regulation: 8.